Ultrasound Markers of Systemic Inflammation

Sponsor
Osijek University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05798182
Collaborator
Josip Juraj Strossmayer University of Osijek (Other)
61
1
12.9
4.7

Study Details

Study Description

Brief Summary

The aim of this study was to measure whether the flow rate through the brachial artery and inflammatory markers were associated with the development of tissue edema in the surgical intensive care unit patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound measurement

Detailed Description

The study was performed using a ultrasound machine with linear probe settings at 50 mm depth and 40 decibel [dB] gain that did not change during the study. The probe was placed on vascular ultrasound measurement. The diameter of the brachial artery in the middle of the upper arm and the flow rate through the artery was measured on postoperative days 1 and 2. The presence of the edema was measured above the 3rd metacarpal bone as the distance from the skin surface to the periosteum. An average of three assessments was shown. Patient's age, body mass index (BMI), type of admission, white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) were also registered.

Study Design

Study Type:
Observational
Actual Enrollment :
61 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Ultrasound in the Intensive Care Unit and Measurable Indicators of Systemic Inflammation
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
ICU patients

Adult patients admitted to the ICU.

Diagnostic Test: Ultrasound measurement
Study was conducted with Mindray T7 ultrasound machine using linear probe. Vascular ultrasound mode was used with settings depth of 50 mm and gain of 40 dB during the entire study period. The diameter and flow velocity of the brachial artery and wrist edema of the fist were measured within 24 hours of admission and the following day.
Other Names:
  • Mindray T7 ultrasound machine
  • Outcome Measures

    Primary Outcome Measures

    1. Diameter of brachial artery - 1 [within 4 hours of admission.]

      Measurement of a brachial artery diameter [cm] at admission. Admission day is considered as day 1.

    2. Diameter of brachial artery - 2 [day 2 after admission is between 24 and 48 hours after admission.]

      measurement of a brachial artery diameter [cm] on day 2 after admission.

    3. Brachial artery flow velocity - 1 [within 4 hours of admission to ICU.]

      measurement of a brachial artery flow velocity [cm/s] at admission.

    4. Brachial artery flow velocity - 2 [day 2 after admission is between 24 and 48 hours after admission.]

      measurement of a brachial artery flow velocity [cm/s] on day 2 after admission. Day 2 is Measurement of a brachial artery flow velocity [cm/s] between 24 and 48 h after ICU admission.

    5. Distance from skin to third metacarpal bone -1 [within 4 hours of admission.]

      measurement of a distance from the skin to third metacarpal bone (cm) at admission.

    6. Distance from skin to third metacarpal bone - 2 [day 2 after admission is between 24 and 48 hours after admission.]

      measurement of a distance from the skin to third metacarpal bone (cm) on day 2 after admission.

    7. White blood cell count - 1 [within 4 hours of admission.]

      blood sample analysis for white blood cell count (WBC [10^9/L]) at admission.

    8. White blood cell count - 2 [day 2 after admission is between 24 and 48 hours after admission.]

      blood sample analysis for white blood cell count (WBC [10^9/L]) on day 2 after admission.

    9. C-reactive protein - 1 [within 4 hours of admission.]

      blood sample analysis for C-reactive protein (CRP [mg/L]) concentration at admission.

    10. C-reactive protein - 2 [day 2 after admission is between 24 and 48 hours after admission.]

      Blood sample analysis for C-reactive protein (CRP [mg/L]) concentration on day 2 after admission.

    11. Procalcitonin - 1 [within 4 hours of admission.]

      blood sample analysis for Procalcitonin concentration (PCT [ug/L]) at admission.

    12. Procalcitonin - 2 [Day 2 after admission is between 24 and 48 hours after admission.]

      Blood sample analysis for Procalcitonin concentration (PCT [ug/L]) on day 2 after admission.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults over 18 years of age

    • Postoperative surgical patients

    • Signed informed consent

    Exclusion Criteria:
    • Refusal to give informed consent

    • A previous thromboembolic event of the brachial artery

    • Acute infection of the upper extremity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Slavica Kvolik Osijek Croatia 31000

    Sponsors and Collaborators

    • Osijek University Hospital
    • Josip Juraj Strossmayer University of Osijek

    Investigators

    • Study Director: Slavica Kvolik, M.D., PhD,, Osijek University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Osijek University Hospital
    ClinicalTrials.gov Identifier:
    NCT05798182
    Other Study ID Numbers:
    • 2158-61-07-21-96
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Osijek University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2023